Companies rush to market at-home STD tests. But are they reliable?

Among the more notable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.

But that quick focus is missing from another, less publicized epidemic: an explosion of sexually transmitted diseases that can cause chronic pain and infertility among infected adults and cripple or kill infected newborns. The disparity has fueled calls from researchers, public health advocates and healthcare companies urging the federal government to greenlight home-testing kits that could greatly increase the number of Americans testing for STDs.

Online shoppers can now choose from more than a dozen self-test kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.

But, with the exception of HIV tests, the Food and Drug Administration has not approved STD test kits for use outside of a medical facility. This leaves consumers unsure of their reliability, even as home use increases dramatically.

The STD epidemic is “out of control,” said Dr. Amesh Adalya, a senior scientist at Johns Hopkins University’s Center for Health Security. “We know we lack diagnoses. We know that contact tracing is done late or not at all. If we’re really serious about tackling the STD crisis, we need to get more people diagnosed.”

Preliminary data for 2021 shows nearly 2.5 million reported cases of chlamydia, gonorrhea and syphilis in the U.S., according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been on the rise for about a decade. In its latest prevalence estimate, the agency said that every day 1 in 5 Americans is infected with one of eight common STDs.

The drive to make home STD testing as easy and common as home testing for COVID and pregnancy comes from several sectors. Public health officials say their overstretched staff cannot keep up with the overwhelming need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in unsatisfied demand.

The medical science supporting STD testing is not particularly new or mysterious. Depending on the test, it may involve taking a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for secretions or cell samples. Medical centers and public health clinics have been performing such tests for decades.

The question for regulators is whether the sampling kits can be reliably adapted for home use. Unlike rapid antigen tests for the coronavirus, which provide results in 15 to 20 minutes, home STD kits on the market require patients to take their own samples, then package and mail them to a lab for analysis.

Over the past three years, as the pandemic has forced clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments — including state agencies in Alabama, Alaska and Maryland — have begun sending out free STD testing kits to the inhabitants. Universities and nonprofits are also spearheading at-home testing efforts.

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And dozens of commercial businesses are starting or increasing direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, said sales of its range of STD kits grew 120% in the first half of this year compared to the first half of 2021.

CVS Health began selling its bundled STD kit in October for $99.99. Unlike most home kits, the CVS version is available in stores.

Hologic, Abbott and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells coronavirus tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who previously led the FDA’s office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to demonstrate that home collection kits are as accurate as those used in clinics and that samples do not degrade during transport.

“The agency does not believe these tests are being sold legally at this point,” said Gutierrez, a partner at NDA Partners, a consulting firm that advises companies looking to bring health care products to market.

“CVS should not be selling this test,” he added.

In response to questions from KHN, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes and sample stabilization chemicals, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action in any particular case, the statement said.

CVS spokeswoman Mary Gattuso said the drugstore chain complies with the law. “We are committed to ensuring that the products we offer are safe, perform as intended, meet regulations and satisfy customers,” Gattuso said.

Everly Health and other companies have described their kits as laboratory-developed tests, similar to diagnostics that some hospitals create for in-house use. And they argue that their tests can be legally marketed because their labs are certified by another agency, the Centers for Medicare & Medicaid Services.

“The tools and assays used by the labs we use are comparable to — and often the same as — those used by the labs used by the doctor’s office,” said Dr. Liz Kuo, Chief Medical Officer at Everly Health. “Our at-home sample collection methods, such as dried blood spots and saliva, have been widely used for decades.”

Home assembly kits appeal to Uxmal Caldera, 27, of Miami Beach, Florida, who prefers to test in the privacy of his own home. Caldera, who does not own a car, said the home tests save him the time and expense of traveling to a clinic.

Caldera has been tested for HIV and other STDs every three months for more than a year, part of the routine monitoring of people taking PrEP, a regimen of daily pills to prevent HIV infection.

“Doing it yourself is not difficult at all,” said Caldera, who is uninsured but gets the tests for free through a community foundation. “The instructions are really clear. I get the results in maybe four days. I would certainly recommend it to other people.”

Dr. Leandro Mena, director of the CDC’s Division of STD Prevention, said he would like to see home STD testing become as routine as home pregnancy tests. An estimated 16 million to 20 million tests for gonorrhea and chlamydia are performed in the U.S. each year, Mena said. Widespread use of home STD testing, he said, could double or triple that number.

He noted that doctors have years of experience using home collection kits.

The Johns Hopkins Center for the Study of Technologies for the Treatment of Sexually Transmitted Diseases has distributed approximately 23,000 home STD kits since 2004, said Charlotte Gaydos, the center’s principal investigator. The FDA usually allows such use if it is part of a study supervised by medical professionals. The center’s tests are now used by the Alaska Department of Health, as well as by Indian tribes in Arizona and Oklahoma.

Gaydos has published dozens of studies finding that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There is a tremendous amount of data showing that home testing works,” Gaydos said.

But Gaydos noted that her studies were limited to small sample sizes. She said she doesn’t have the millions of dollars in funding that would be needed to conduct the kind of comprehensive testing the FDA typically requires for approval.

Jenny Mann, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “Public health labs won’t touch it without the FDA’s blessing,” Mann said.

Public health clinics often provide STD testing for little or no cost, while health insurance usually covers in-person testing in a private practice. But most consumers pay out of pocket for direct-to-consumer kits. Commercial pricing makes them unaffordable for many people, especially teenagers and young adults, who account for nearly half of STDs.

Adalya of Johns Hopkins said the FDA has a history of moving slowly on domestic testing. The agency spent seven years evaluating the first home HIV test it approved, which went on the market in 2012.

“Home testing is the way of the future,” said Laura Lindberg, a professor of public health at Rutgers University. “The pandemic has opened the door to testing and treatment at home without traveling to a healthcare provider, and we won’t be able to put the genie back in the bottle.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Along with policy analysis and polling, KHN is one of three major operational programs in the KFF (Kaiser Family Foundation). KFF is a charitable, non-profit organization providing information on health issues to the nation.

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